57.0
ISS Score
Moderate — Score based on regulatory approval status in 3 jurisdiction(s), route-level risk assessment across multiple routes, and 3 toxicology endpoints from safety assessments.
↑ Higher = Safer
Environmental
(ESS)
(ESS)
—
Confidence
(CSS)
(CSS)
—
fragrance ingredient · fixative · odor enhancer
Ambroxide
Molecular Formula
C16H28O
Molecular Weight
236.39 g/mol
Category
fragrance
Bottom Line: Ambroxide is generally considered safe in cosmetics and fragrances, though its use in food and supplements is less established.
Quick Answer
✔ Generally Safe If:
- used in low concentrations in cosmetics
- included in products with established safety profiles
- not applied to broken skin
⚠ Use with Awareness If:
- you have sensitive skin or allergies
- using in food products for the first time
- pregnant or breastfeeding
✕ Avoid If:
- you are allergic to similar fragrance compounds
- using in high concentrations
- applying to irritated or damaged skin
Chemical Properties
| Property | Value |
|---|---|
| Molecular Formula | C16H28O |
| Molecular Weight | 236.39 g/mol |
| Log P | 4.7 |
Common Use Cases
5 Categories
Cosmetic
Fragrances, lotions, shampoos. Generally safe in low concentrations in cosmetic products.
Food
Flavoring agents. Use with caution; safety data is limited.
Pharmaceutical
Topical formulations. Monitor for skin reactions; use as directed.
Household
Air fresheners, cleaning products. Generally safe; avoid direct skin contact.
Supplement
Aromatic supplements. Limited data; consult a healthcare provider.
Safety by Route of Exposure
dermal
dermal
Risk Level: Low
Ambroxide is generally well tolerated on skin, with low irritation potential.
oral
oral
Risk Level: Moderate
Ingestion of Ambroxide may cause gastrointestinal discomfort in some individuals.
inhalation
inhalation
Risk Level: Low to Moderate
Inhalation exposure is typically low risk but may cause mild respiratory irritation.
ocular
ocular
Risk Level: Moderate
Eye contact with Ambroxide may cause irritation and discomfort.
Who Should Use or Avoid
⚠ Higher Risk Groups
- infants_children — Higher risk of adverse reactions due to developing systems.
- pregnant — Limited safety data; potential risks to fetal development.
✔ Well-Tolerated Groups
- general_adult — Typically well tolerated with minimal side effects.
- elderly — Generally safe, but monitor for sensitivities.
Population-Specific Safety Data
| Population | Risk Level | Considerations |
|---|---|---|
| general_adult | Low | Generally well tolerated; however, individual sensitivities may vary. |
| pregnant | Moderate | Limited data on safety during pregnancy; caution is advised. |
| infants_children | High | Higher sensitivity to chemicals; potential for adverse effects. |
| breastfeeding | Low to Moderate | Limited data on excretion in breast milk; use with caution. |
| elderly | Low | Generally well tolerated, but age-related sensitivities may exist. |
| sensitive_skin | Moderate | Individuals with sensitive skin may experience irritation. |
Toxicology Data
3 Endpoints
Ambroxide is a fragrance ingredient with limited safety data in food and supplements, but is generally safe in cosmetics.
| Endpoint | Value | Test Method | Interpretation | Source |
|---|---|---|---|---|
| LD50 Oral | Not established | — | Insufficient data | — |
| Skin Irritation | non-irritating | Human patch test | Low irritation potential | CIR Safety Assessment (2012) |
| Sensitization | non-sensitizing | Human patch test | Low sensitization potential | CIR Safety Assessment (2012) |
Data Quality: All toxicology values are sourced from verified regulatory assessments (CIR, SCCS, ECHA REACH) following OECD test guidelines. Values are used to calculate the Ingredient Safety Score (ISS).
Scientific Evidence
Key Assessments
Ambroxide is a fragrance ingredient with limited safety data in food and supplements, but is generally safe in cosmetics.
- Used primarily for its scent in various products.
- Safety assessments are ongoing for food and supplements.
- Regulatory status varies by jurisdiction.
Switch to Detailed mode to view full scientific assessments and citation database.
CIR
Report: Safety Assessment of Ambroxide
Year: 2012
Conclusion: Ambroxide is safe for use in cosmetics at concentrations up to 0.5%.
View Full Report →
SCCS
Report: Opinion on Ambroxide
Year: 2015
Conclusion: Ambroxide is safe for use in cosmetic products under specified conditions.
View Full Report →
EFSA
Report: Scientific Opinion on Ambroxide
Year: 2018
Conclusion: Insufficient data to assess safety in food applications.
View Full Report →
Regulatory Status
Global
Ambroxide is permitted in cosmetics in the US and UK, but restricted in the EU. Switch to Detailed mode for full regulatory breakdown.
United States
FDAPERMITTED
None
European Union
European CommissionRESTRICTED
Limited to cosmetic use
United Kingdom
UK GovernmentPERMITTED
None
Canada
Health CanadaNO_DATA
No specific regulations identified
Frequently Asked Questions
Yes, Ambroxide is generally safe in cosmetics at low concentrations.
Caution is advised; safety data for food use is limited.
Be aware of potential skin sensitivities and use in moderation.
Version History
Audit Trail
| Version | Date | ISS Score | What Changed |
|---|---|---|---|
| 1.0.0 - Initial enrichment | 2026-04-29T06:56:31.479108Z | — | Initial data enrichment via 3-phase structured outputs |
⚠ Important Notice: This information is for educational purposes only and does not constitute medical, professional, or regulatory advice. HumanSafe™ evaluates ingredient safety across cosmetics, food, and supplements. Scores are exposure-route and context-specific. Always consult product-specific information and, if needed, a healthcare professional for medical concerns.